• Insulin
• Diabetes & Endocrinology Clinical Trials
• Prevention & Screening
• Hyperglycemia/Hypoglycemia

• Insulin
• Diabetes & Endocrinology Clinical Trials
• Prevention & Screening
• Hyperglycemia/Hypoglycemia
• Endocrinology
• Diabetes & Metabolic Syndrome

Education concerning hypoglycemia benefits patients with type 1 diabetes (T1D) with impaired awareness of hypoglycemia, regardless of the system used to deliver insulin and monitor blood glucose, according to Stuart Little, MBBS, Newcastle University, Newcastle, United Kingdom, who reported on the Prevention of Recurrent Severe Hypoglycaemia: A Definitive Randomized Controlled Trial Comparing Optimised MDI and CSII With or Without Adjunctive Real-time Continuous Glucose Monitoring [HypoCOMPaSS; EUCTR2009-015396-27].

Typically, ∼25% of patients with T1D have an impaired awareness of hypoglycemia. This lack of knowledge can lead to a markedly higher risk of life-threatening episodes of severe hypoglycemia.

In this study, 96 T1D patients with impaired awareness of hypoglycemia were randomized to either the conventional multiple daily injections of insulin aspart or insulin glargine (n=50) or pump-mediated delivery of insulin aspart (n=46). In both groups, glucose was either episodically or continuously monitored. All participants received a standardized 2-hour information program concerning the recognition of risk factors and symptoms of hypoglycemia, which proved equally effective in reducing episodes of hypoglycemia. The primary endpoint was the difference in awareness of hypoglycemia as determined using the Gold score at 24 weeks. Secondary endpoints were measures of overall glycemic control and patient reported outcomes including fear of hypoglycemia and treatment satisfaction.

The participants had a mean age of 49 years (range, 18 to 74 years), mean duration of diabetes of 29 years, and were C-peptide negative. Their impaired awareness of hypoglycemia was ≥4, as measured using the Gold score, which queries knowledge of the onset of hypoglycemia, with the response ranked on a 7-point scale ranging from 1 (“always aware”) to 7 (“never aware”) [Gold AE et al. Diabetes Care 1994]. Two thirds of the participants were women, two thirds had retinopathy, one quarter had nephropathy, and one quarter had concomitant immune-treated thyroid disease. The mean HbA1C level was 8.2%.

By 4 weeks, biochemical hypoglycemia measured by continuous monitoring was significantly reduced from 53.3 minutes (3.7% of time) to 24.5 minutes (1.7% of time), ∼30 minutes less each day (p<0.001 vs baseline). The reduction was sustained over the remaining 20 weeks. At 24 weeks, a statistically significant improvement in the median Gold score from 5 to 4 was evident for all participants regardless of the method of insulin, compared with the baseline score (p<0.001).

The number of episodes of severe hypoglycemia, defined by the American Diabetes Association as hypoglycemia that requires assistance for treatment, was reduced from 9 at baseline to <1 at 24 weeks (p<0.001), with the proportion of patients affected declining from 92% and 77% at 1 year and 6 months prior to the trial, respectively, to just 19% during the trial.

The mean number of insulin doses decreased significantly by about 8 units over the 24-week trial (p<0.001). Both treatment arms displayed similarities in HbA1C values, Gold score, number of episodes of severe hypoglycemia, mean insulin dose, and fear of hypoglycemia. Participants who received insulin via a pump expressed greater satisfaction with treatment.

Prof. Little and his colleagues concluded that impaired awareness of hypoglycemia can be improved and recurrent hypoglycemia can be prevented through strategies targeted at avoiding severe biochemical hypoglycemia in a high-risk population affected by diabetes for almost 30 years. This benefit of education is more influential than the technology of insulin delivery.

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